VALCHLOR® (mechlorethamine) gel is a prescription medicine used on the skin to treat people with Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who have received previous skin treatment. It is not known if VALCHLOR is safe and effective in children.

Artistic rendition of Stage IA/IB MF‑CTCL. Not an actual patient.

*In a clinical study, 119 VALCHLOR patients were evaluated over a 12-month period. 45.4% (54 out of 119 patients) experienced a partial response to the medication and 14.3% (17 out of 119 patients) achieved a complete response or clear skin in up to 5 index lesions. A complete response was achieved when the Composite Assessment of Index Lesion Severity (CAILS) score was 0, combining skin lesion ratings for redness, scaling, plaque elevation, and surface area.

VALCHLOR is a clear gel option to help patients with Stage IA/IB MF-CTCL.Ask your doctor if VALCHLOR is right for you.

Save money by paying no more than $10 per prescription fill, if eligible

The VALCHLOR copay program is only available for US and Puerto Rico residents who are 18 or older and have commercial health insurance with copay/coinsurance exceeding $10 per prescription fill. Patients ineligible for the VALCHLOR copay program include those enrolled in Medicare, Medicaid, VA/DoD (Tricare), the Indian Health Service, or any other federal- or state- funded healthcare program, or where prohibited by law. The VALCHLOR copay program is not prescription drug coverage or insurance. Helsinn Therapeutics, Inc. reserves the right to terminate or modify this program at any time without notice. Other terms and conditions apply.

IMPORTANT SAFETY INFORMATION

VALCHLOR® (mechlorethamine) gel is for use on skin only. Do not get VALCHLOR near or in your eyes, mouth, or nose as it can cause pain, redness, swelling, burning, and ulcers. It can also cause sensitivity to light, blurred vision, and may also cause blindness or permanent eye injury. If VALCHLOR gets in your eyes, rinse your eyes right away for at least 15 minutes with a large amount of water, normal saline, or an eyewash solution. If it gets in your nose or mouth, rinse the affected area right away for at least 15 minutes with a large amount of water. Get medical help right away.

Do not use VALCHLOR if you are severely allergic to mechlorethamine. Tell your healthcare provider if you have had an allergic reaction to mechlorethamine.

Before using VALCHLOR, tell your healthcare provider about all your medical conditions. In addition, if you are pregnant, planning a pregnancy, or breastfeeding:

VALCHLOR can harm your unborn baby and you should not become pregnant while using VALCHLOR. Tell your healthcare provider if you are planning to get pregnant, are pregnant, or become pregnant while using VALCHLOR

It is not known if VALCHLOR passes into breast milk. You and your healthcare provider should decide if you will use VALCHLOR or breastfeed; do not do both

VALCHLOR is flammable. Avoid fire, flame, and smoking until VALCHLOR has dried.

SERIOUS SIDE EFFECTS INCLUDE:

Risk of secondary exposure to VALCHLOR for caregivers who accidentally come into contact with VALCHLOR may include risk of skin inflammation (dermatitis); injury to eyes, mouth, or nose; and certain types of cancer. If accidental contact occurs, wash the affected area with soap and water right away for at least 15 minutes and remove any contaminated clothing. Get medical help right away if VALCHLOR gets in your eyes, mouth, or nose.

Skin inflammation (dermatitis) is common with VALCHLOR and may sometimes be severe. Risk for dermatitis is increased if VALCHLOR is applied to your face, genital area, anus, or skin folds. Tell your healthcare provider if you develop skin reactions such as redness, swelling, itching, blisters, ulcers, and skin infections.

Increased risk of certain types of skin cancers. Certain types of skin cancer can develop on treated and non-treated areas with VALCHLOR. Your healthcare provider will check your skin for skin cancers during and after treatment. Tell your healthcare provider if you get any new skin lesions.

Most common side effects include redness, swelling, itching, skin ulcers or blisters, skin infection, and darkening of areas of your skin.

These are not all the possible side effects of VALCHLOR. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Keep VALCHLOR and all medicines out of the reach of children.

Applying VALCHLOR

When applying VALCHLOR, caregivers must wear disposable nitrile gloves, which should be safely thrown away in the household trash. Wash hands with soap and water after touching or applying VALCHLOR. Apply right away or within 30 minutes once taken out of the refrigerator. Refrigerate VALCHLOR right after each use. Apply a thin layer to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Let treated area dry for 5 to 10 minutes after applying VALCHLOR before covering with clothing. Moisturizers may be applied to the treated areas 2 hours before or 2 hours after applying VALCHLOR. Do not use airtight or watertight bandages on areas treated with VALCHLOR.

IMPORTANT SAFETY INFORMATION

VALCHLOR® (mechlorethamine) gel is for use on skin only. Do not get VALCHLOR near or in your eyes, mouth, or nose as it can cause pain, redness, swelling, burning, and ulcers. It can also cause sensitivity to light, blurred vision, and may also cause blindness or permanent eye injury. If VALCHLOR gets in your eyes, rinse your eyes right away for at least 15 minutes with a large amount of water, normal saline, or an eyewash solution. If it gets in your nose or mouth, rinse the affected area right away for at least 15 minutes with a large amount of water. Get medical help right away.

Do not use VALCHLOR if you are severely allergic to mechlorethamine. Tell your healthcare provider if you have had an allergic reaction to mechlorethamine.

Before using VALCHLOR, tell your healthcare provider about all your medical conditions. In addition, if you are pregnant, planning a pregnancy, or breastfeeding:

VALCHLOR can harm your unborn baby and you should not become pregnant while using VALCHLOR. Tell your healthcare provider if you are planning to get pregnant, are pregnant, or become pregnant while using VALCHLOR

It is not known if VALCHLOR passes into breast milk. You and your healthcare provider should decide if you will use VALCHLOR or breastfeed; do not do both

VALCHLOR is flammable. Avoid fire, flame, and smoking until VALCHLOR has dried.

SERIOUS SIDE EFFECTS INCLUDE:

Risk of secondary exposure to VALCHLOR for caregivers who accidentally come into contact with VALCHLOR may include risk of skin inflammation (dermatitis); injury to eyes, mouth, or nose; and certain types of cancer. If accidental contact occurs, wash the affected area with soap and water right away for at least 15 minutes and remove any contaminated clothing. Get medical help right away if VALCHLOR gets in your eyes, mouth, or nose.

Skin inflammation (dermatitis) is common with VALCHLOR and may sometimes be severe. Risk for dermatitis is increased if VALCHLOR is applied to your face, genital area, anus, or skin folds. Tell your healthcare provider if you develop skin reactions such as redness, swelling, itching, blisters, ulcers, and skin infections.

Increased risk of certain types of skin cancers. Certain types of skin cancer can develop on treated and non-treated areas with VALCHLOR. Your healthcare provider will check your skin for skin cancers during and after treatment. Tell your healthcare provider if you get any new skin lesions.

Most common side effects include redness, swelling, itching, skin ulcers or blisters, skin infection, and darkening of areas of your skin.

These are not all the possible side effects of VALCHLOR. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Keep VALCHLOR and all medicines out of the reach of children.

Applying VALCHLOR

When applying VALCHLOR, caregivers must wear disposable nitrile gloves, which should be safely thrown away in the household trash. Wash hands with soap and water after touching or applying VALCHLOR. Apply right away or within 30 minutes once taken out of the refrigerator. Refrigerate VALCHLOR right after each use. Apply a thin layer to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Let treated area dry for 5 to 10 minutes after applying VALCHLOR before covering with clothing. Moisturizers may be applied to the treated areas 2 hours before or 2 hours after applying VALCHLOR. Do not use airtight or watertight bandages on areas treated with VALCHLOR.